Ranibizumab in Subjects With Dense Cataract and Rubeosis Due to Proliferative Diabetic Retinopathy (PDR)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Adverse Event (AE)
研究概览
简要总结
The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).
详细描述
This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.
All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Subjects with diabetes mellitus
- •Subjects with proliferative diabetic retinopathy induced rubeosis
- •Be willing to undergo cataract surgery
- •HgbA1c level < 12%
排除标准
- •History of glaucoma surgery
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
- •Intraocular surgery in the study eye within 60 days preceding Day 0
- •History of prior pars plana vitrectomy in the study eye
- •Positive pregnancy test
- •HbA1c >12
研究组 & 干预措施
Treatment
All subjects enrolled received treatment with identical dosage of Ranibizumab
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Adverse Event (AE)
时间窗: first 12 months
Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR).
次要结局
- Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA)(months 3, 7 and 12)
- Presence of Proliferative Diabetic Retinopathy (PDR)(at month-12)
- Macular Volume(at months-1,3,7, and 12)
- Mean Time to Re-treatment(first 12 months)
- Mean Number of Ranibizumab Injections(first 12 months)
- Mean Number of PRP Laser Treatments(first 12 months)
- Mean Change in Intraocular Pressure (IOP)(at months-3,7, and 12)